Last but not least, Dr. Mike Wang, Complications and Revision Rates in Robotic-Guided Versus Fluoroscopic-Guided Minimally Invasive Lumbar Fusion Surgery, reports from the MIS Refresh Prospective Comparative Study. Thanks, Lou. Wow, you guys are ahead of time. That's great moderators. So thanks for letting me present some data. This interim analysis from the refresh group, these are my co-investigators, pretty good mix of ortho and neuro spine surgeons, mostly in private practice, actually. So, I mean, we all know the benefits of MIS surgery and it's kind of run its course for 15 years. The question now is going to be whether new technology is going to make a difference, right? So you don't have to go far in exhibit hall to see all these new robotic devices. This study looked at the original Mazor Renaissance, which is a first generation robot, which has been around for about 15 years. And there's a lot of things to look at, including the economic ramifications, which we're not going to look at, and surgeon longevity. But those are things I want you to be thinking about in terms of what the robot may be doing for you. For this study, we just were interested in comparing fluoro versus robot guided MIS surgery. These are all basically short segment lumbar fusions for this particular analysis. And the study's been running for about almost four years now. And these centers are doing these surgeries not on a randomized sort of a basis, but it's prospective data collection, very high quality data collection, almost like an FDA trial. But it is not controlled in terms of surgeon bias and selection. So that's one of the issues here. And so this paper reflects analysis of the complications. And here we're talking specifically about neuro deficits, CSF leaks, infections requiring operative IND, hardware removal, and vertebral body fractures. And we also looked at floor exposure. So this kind of shows results. And this table demonstrates that there is a difference between these groups. So these are not controlled patients. If you look, for example, at the age difference, right, there was a difference in terms of the robot patients being younger at 58 versus 62 for the floral base. And that just gives you some idea that the data, you know, it's not locked down like a controlled trial. But it's a fairly sizable group with 422 people or patients involved in general. If you look at the floral or X-ray exposure involved, you can see very significant differences in terms of the amount of radiation delivered per screw or per case. And that should be no surprise to anybody, right, that basically when you're using a robot, even for a short segment surgery, you're getting some benefit in terms of the image guidance and the robotic arm pieces of it, right? More interesting than that is the complication and revision rate. Now, I was surprised by this because I figured, wow, you know, people are going to have screws put in, they're going to have a T-lift, and the complication rates may be slightly different but not much. And the reality is that we saw a sizable difference in complications, 13.8 versus 31.8 percent in terms of complications, and revision rates almost tripled, 1.6 percent versus 4.5 percent. So reasonable in terms of revisions, complications were fairly high, and if you look at it in terms of the hazard ratio, pretty significant, 3.1 versus 14.7 for complications and revisions. And this was not just at the, you know, people are like, well, that's the operative event, right, so misplaced screw, we can understand that. But this Kaplan-Meier curve shows that if you look at the complication-free survival, this extends out over time. So what are these complications, right? So it turns out there are all kinds of other things that happen, such as adjacent segment disease and fractures and whatnot, and these are occurring more in the floral-guided cases, right? So somehow, and this has been something that's been hard to explain, is there some implicit bias in how we're selecting patients because the study's not controlled that way? I mean, the results are pretty startling, and there must be some bias here, but it couldn't explain all of this. Now, some people say, well, look at the difference in terms of the size of your constructs, right? So if you look at robotic versus floral, of course we're doing more longer segment surgeries with the robot. So why don't we just isolate the single-level cases? So this shows the relative distribution, but let's just look at single cases for subgroup analysis, and we see a similar finding that complication rates lower, of course, because they're shorter surgeries, 13.9 versus 34.8 percent, and revisions, again, 1.5 versus 3.4. So even if we say, look, let's take the simplest, smallest surgery, which many people would say I wouldn't even use the robot for, maybe we're seeing differences. Maybe there's less tissue destruction. Maybe we're preserving the soft tissue envelope better. Maybe we're targeting better and destroying less of the body. And this shows that same Kaplan-Meier complication-free survival rate over time, up to 400 days. Again, this is just one-level construct, so you see a difference that matches that larger cohort of one- and multiple-level surgeries. So the bottom line is, in our study, fewer complications when you're using first-generation robot, 3.1 time lower risk of a complication, less revisions, and less floral time. But, of course, there's a lot of caveats, right? Our control arm was only 110 patients. There were only two surgeons that were in the control arm, so there's probably some bias there. And our follow-up is still somewhat limited. But this is an ongoing trial that's still running out. So I look forward to giving you more data on this and in more detail in the future. Thank you. Thank you. Thanks, Mike.

Dr. Mike Wang

MIS Refresh Prospective Comparative Study

robotic-guided

fluoroscopic-guided

minimally invasive lumbar fusion surgery